This invention relates generally to medical devices, and particularly to balloon catheters, including angioplasty and stent delivery balloon catheters.
In percutaneous transluminal coronary angioplasty (PTCA) procedures, a guiding catheter is advanced until the distal tip of the guiding catheter is seated in the ostium of a desired coronary artery. A guidewire, positioned within an inner lumen of a dilatation catheter, is first advanced out the distal end of the guiding catheter into the patient's coronary artery until the distal end of the guidewire crosses a lesion to be dilated. Then the dilatation catheter having an inflatable balloon on the distal portion thereof is advanced into the patient's coronary anatomy, over the previously introduced guidewire, until the balloon of the dilatation catheter is properly positioned across the lesion. Once properly positioned, the dilatation balloon is inflated with liquid one or more times to a predetermined size at relatively high pressures (e.g. greater than 8 atmospheres) so that the stenosis is compressed against the arterial wall and the wall expanded to open up the passageway. Generally, the inflated diameter of the balloon is approximately the same diameter as the native diameter of the body lumen being dilated so as to complete the dilatation but not overexpand the artery wall. Substantial, uncontrolled expansion of the balloon against the vessel wall can cause trauma to the vessel wall. After the balloon is finally deflated, blood flow resumes through the dilated artery and the dilatation catheter can be removed therefrom.
In such angioplasty procedures, there may be restenosis of the artery, i.e. reformation of the arterial blockage, which necessitates either another angioplasty procedure, or some other method of repairing or strengthening the dilated area. To reduce the restenosis rate and to strengthen the dilated area, physicians frequently implant an intravascular prosthesis, generally called a stent, inside the artery at the site of the lesion. Stents may also be used to repair vessels having an intimal flap or dissection or to generally strengthen a weakened section of a vessel. Stents are usually delivered to a desired location within a coronary artery in a contracted condition on a balloon of a catheter which is similar in many respects to a balloon angioplasty catheter, and expanded to a larger diameter by expansion of the balloon. The balloon is deflated to remove the catheter and the stent left in place within the artery at the site of the dilated lesion.
In the design of catheter balloons, balloon characteristics such as strength, flexibility and compliance must be tailored to provide optimal performance for a particular application. Angioplasty balloons preferably have high strength and a high rupture pressure for inflation at relatively high pressure, and high flexibility and softness for improved ability of the catheter to track the tortuous anatomy and cross lesions. The balloon compliance is chosen so that the balloon will have a desired amount of expansion during inflation. Compliant balloons exhibit substantial stretching upon application of internal pressure, whereas noncompliant balloons exhibit relatively little stretching during inflation.
In the manufacture of catheter balloons, a variety of methods have been used to sterilize the catheter before use including exposure to an electron beam (i.e., e-beam) or a sterilizing fluid such as ethylene oxide (i.e., EtO). One difficulty has been sterilizing polymeric materials which degrade substantially in response to a conventional sterilization method. Degradation of the polymeric material will reduce the rupture pressure of the catheter balloon. Increasing the wall thickness of such balloons to provide an acceptably high rupture pressure increases the profile and stiffness of the balloon, and consequently decreases the trackability and crossability of the catheter in the patient's vasculature. Thus, what has been needed is an improved method of sterilizing medical devices.